Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

Phase 3

Terminated

• Conditions: Myelodysplastic Syndrome; Acute Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Myeloproliferative Disease; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia
• Interventions: Drug: ARM A Cyclophosphamide; Drug: ARM B Calcineurin inhibitor and methotrexate

• Registration Number: NCT01749111
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

Detailed Description

We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Man or woman 18 to 60 years of age.
• The patient should have a HLA matched donor
• The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
• Patients want to participate in the study, and able to give informed consent.

Exclusion Criteria

• Previous auto o allogeneic hematopoietic stem cell transplant
• Performance Status >2 (ECOG).
• Pregnancy
• HIV positive
• Active Infection
• Cardiac disease with ejection fraction < 45%
• Lung disease with FEV1, FVC ou DLCO <50% of predicted values.
• Renal Insufficiency with creatinine clearance < 60 ml/minute.
• Liver disease with bilirubin levels > twice the reference value or ALT or AST > three times the normal reference.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	ARM A Cyclophosphamide	Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
Arm B	ARM B Calcineurin inhibitor and methotrexate	In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis

Primary Outcome Measures

Name	Time	Method
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.	one year	The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation	one year	Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation

Trial Locations

Locations (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP); 🇧🇷 São Paulo, Brazil